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USFDA gives exception to Ipca Laboratories for APIs Chloroquine Phosphate and Hydroxychloroquine Sulphate and its formulations

Posted On: 2020-03-21 12:26:37

Due to the shortage implications and/or medical necessity of certain drugs and finished products, the United States Food and Drug Administration (FDA) vide its e-mails dated 20th March, 2020 has made exception to the import alert for the Company's following Active Pharmaceutical Ingredients (APIs) and finished products (Formulations):

- Hydroxychloroquine Sulphate and Chloroquine Phosphate APIs produced at the Company's APIs manufacturing unit situated at Ratlam (Madhya Pradesh); and

- Hydroxychloroquine Sulphate Tablets produced at the Company's formulations manufacturing units situated at SEZ Indore, Pithampur (Madhya Pradesh) and Piparia (Silvassa).

US FDA has also informed that their exception will be re-considered if the shortage implications change.

We also wish to bring to your notice several credible articles / reports / research papers claiming prophylactic as well as treatment potentials of Chloroquine Phosphate and Hydroxychloroquine Sulphate formulations in managing/treating Coronavirus Disease (Covid-19), though these drugs are not approved for treatment by any regulatory authority. Due to this, we are noticing an increase in the emergency demand and enquiries for the Chloroquine Phosphate and Hydroxychloroquine Sulphate APIs and its formulations from several countries world over.

Forseeing this increased demand, Ipca being amongst largest manufacturer, vertically integrated with capacities and capabilities for manufacturing of these APIs and its formulations, is gearing to manufacture and supply these products meeting the stringent cGMP, quality and regulatory requirements and thus help mankind in the best possible way in these testing times.

Shares of IPCA LABORATORIES LTD. was last trading in BSE at Rs.1371.85 as compared to the previous close of Rs. 1260.1. The total number of shares traded during the day was 50105 in over 8918 trades.

The stock hit an intraday high of Rs. 1500 and intraday low of 1310. The net turnover during the day was Rs. 70448314.

Source: Equity Bulls

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